Clinical trial · Interventional
Charcoal in Lung Cancer Patients Undergoing TEMLA
Safety of Oral Activated Charcoal and Its Effect on the Gut Microbiome In Patients With Lung Cancer Undergoing Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Because of logistic challenges and lack of product among other factors, we decided to completely withdrawn this study.
Summary
Brief summary (as posted)
This proof-of-concept study serves as the preliminary step to prove safety of oral activated charcoal (OAC) in patients with solid tumors before moving to a hematologic malignancy patient population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated charcoal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adults undergoing TEMLA
- description
- Adults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery
- interventionNames
- Drug: Activated charcoal
Primary outcomes (1)
- measure
- Number of patients who are free from analgesics within 3 days of TEMLA
- timeFrame
- 3 days after surgery
- description
- The duration of analgesic medication use after a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is observed and the number of patients who are free from analgesics is reported
Secondary outcomes (4)
- measure
- Number of patients experiencing gastrointestinal adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is planned * Planned pre-procedural IV antibiotic. The choice of antibiotic type is up to the treatment physician(s) * Able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery * 18 years of age or older * Able to provide written consent prior to any research related activities Exclusion Criteria: * Current pregnancy or breastfeeding (SOC pre-TEMLA testing/assessment) * Any current diagnosed disease with known involvement of the gastrointestinal tract * Known allergy to oral activated charcoal * CTCAE v 5 Dysphagia Grade 2 (symptomatic and altered eating/swallowing) or greater * Known risk of aspiration based on history or current complaints * Gastrointestinal procedures within 2 weeks before or (planned) after TEMLA * Systemic antibiotic use within 8 weeks before planned TEMLA
References
Publications (0)
Data not yet available